ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation

NAActive, not recruitingINTERVENTIONAL
Enrollment

203

Participants

Timeline

Start Date

July 14, 2021

Primary Completion Date

September 4, 2024

Study Completion Date

January 31, 2026

Conditions
Chronic Low-back Pain
Interventions
DEVICE

ReActiv8

Market-approved ReActiv8 device implanted

Trial Locations (28)

10022

Ainsworth Institute of Pain Management, New York

11021

Northwell Health, Great Neck

17601

Center for Interventional Pain and Spine, Lancaster

20006

International Spine, Pain and Performance Center, Washington D.C.

27103

The Center for Clinical Research, LLC, Winston-Salem

27710

Duke University, Durham

28207

OrthoCarolina Sports Medicine Center, Charlotte

30214

Horizon Clinical Research, Fayetteville

30265

Vista Clinical Research, Newnan

30909

Augusta Orthopedic & Sports Medicine Specialists, Augusta

33407

Cantor Spine Center and Paley Orthopedic Spine Institute, West Palm Beach

34986

Cleveland Clinic Martin Health Tradition Hospital, Port Saint Lucie

44106

University Hospitals Cleveland, Cleveland

44195

Cleveland Clinic, Cleveland

46032

Indiana Spine Group, Carmel

46278

OrthoIndy, Indianapolis

64804

Freeman Hospital, Joplin

65109

SSM Health Medical Group, Jefferson City

65201

Columbia Orthopedic Group, Columbia

66160

University of Kansas Medical Center, Kansas City

66204

Advent Health Shawnee Mission, Shawnee Mission

72205

University of Arkansas for Medical Sciences, Little Rock

80045

University of Colorado, Aurora

85013

Barrow Brain & Spine, Phoenix

92660

SoCal Sport and Spine, Newport Beach

95403

Pacific Research Institute, Santa Rosa

97062

Spinal Diagnostics, PC, Tualatin

97401

Pacific Sports and Spine, Eugene

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mainstay Medical

INDUSTRY

NCT04803214 - ReActiv8 Stimulation Therapy vs Optimal Medical Management: A Randomized Evaluation | Biotech Hunter | Biotech Hunter